PMA P810006S036

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE,COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S036
Product code: LMF
Decision date: 2013-11-29
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR THE FOLLOWING PROPOSED CHANGES: 1) CHANGE IN CLEANING DETERGENTS; 2) ESTABLISHMENT OF EQUIPMENT DIRTY HOLD TIMES (DHT); AND 3) PROPOSED USE OF TOTAL ORGANIC CARBONS (TOCS) AS A METHOD TO TEST FOR RESIDUES.

Current openFDA PMA Record#

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE,COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S036
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2013-11-29
Decision code: APPR
Date received: 2013-05-01
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE FOLLOWING PROPOSED CHANGES: 1) CHANGE IN CLEANING DETERGENTS; 2) ESTABLISHMENT OF EQUIPMENT DIRTY HOLD TIMES (DHT); AND 3) PROPOSED USE OF TOTAL ORGANIC CARBONS (TOCS) AS A METHOD TO TEST FOR RESIDUES.